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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06278298
Other study ID # REC/012/003318
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)


Description:

The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date January 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - Criteria of selecting the patients from hospital included the following; 1. Their ages ranged from 30 to 50 years. 2. All patients were examined carefully by physician before the study procedure. 3. All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema. 4. They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention. 5. Only ambulant subjects without any aides will be selected. 6. The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ). 7. All patients will be medically stable. 8. Each patient will sign a consent form which in that insures her eligibility in the study. 9. All patients were treated by the same doctor and physiotherapist. Exclusion Criteria: - The subjects had been excluded from the study if they met one of the following criteria; 1. The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases. 2. Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded. 3. The patients had neurological or orthopedic problems, and diabetes. 4. Patients with primary lymphedema. 5. Cardiopulmonary disease which decrease the patient activites.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Shockwave
CDT and different dose of shockwave
Other:
CDT
CDT

Locations

Country Name City State
Egypt Cairo University Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary lymphedema volume tape measurment two months
Primary skin thickness of the arm ultrasonography two months
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